Label: ADVANCED FLUORIDE ANTICAVITY- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 29500-9181-6 - Packager: Personal Care Products, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 1, 2017
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- Official Label (Printer Friendly)
- Active IngredientDrug Facts
- Purpose
- Use
- Warnings
- Keep out of reach of children
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Directions
adults and children 2 years. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist.
do not swallow
to minimize swallowing, use a pea-sized amount in children under 6 years old
supervise children's brushing until good habits are established
children under 2y ears: ask a dentist before use.
- inactive ingredients
- ADVANCED FLUORIDE ANTICAVITY product label
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INGREDIENTS AND APPEARANCE
ADVANCED FLUORIDE ANTICAVITY
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-9181 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1000 mg in 181 g Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) POWDERED CELLULOSE (UNII: SMD1X3XO9M) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM OXIDE (UNII: LMI26O6933) HYDRATED SILICA (UNII: Y6O7T4G8P9) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29500-9181-6 1 in 1 PACKAGE 07/24/2017 1 181 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 07/24/2017 Labeler - Personal Care Products, LLC (966155082) Registrant - Personal Care Products, LLC (966155082)